NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hcl tablet, film coated 
WinCo Foods, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Winco 44-453

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg 

Purpose

Nasal decongestant 

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure 

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur 
  • symptoms do not improve within 7 days or occur with fever

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide 

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST 

Principal Display Panel

WinCo®
FOODS

MAXIMUM STRENGTH 
Nasal
Decongestant PE

*Compare to the active ingredient
in SUDAFED PE® Sinus Congestion

Non-Drowsy

Relieves: Sinus Pressure
& Nasal Congestion

PHENYLEPHRINE HCl 10 mg/
NASAL DECONGESTANT

72
Tablets

DISTRIBUTED BY:
WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed
by JOHNSON & JOHNSON CORPORATION,
distributor of SUDAFED PE® Sinus Congestion.

50844    REV0820B45323    WF2208

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING

The Supermarket Low Price Leader®
100% SATISFACTION GUARANTEE

Comments & Questions?
800-824-1706 • www.wincofoods.com

Winco 44-453

Winco 44-453

NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-207-181 in 1 CARTON01/14/2005
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:67091-207-723 in 1 CARTON01/14/2005
224 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/14/2005
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(67091-207) , pack(67091-207)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(67091-207)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(67091-207)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(67091-207)

Revised: 9/2022
 
WinCo Foods, LLC